RAC Exam Study Guide with Complete Solutions drug - Correct Answer Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.medical device - Correct Answer An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on man or other animals intended to affect the structure of any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body, and which is not dependent upon being metabolized for the achievement of its primary intended purposes (FD&C Act Section 201) DRLS - Correct Answer Drug Registration and Listing System FURLS - Correct Answer FDA Unified Registration and Listing System for establishment registration of medical device operators and distrubutors).eDRLS - Correct Answer electronic Drug Registration and Listing System MDUFMA - Correct Answer Medical Device User Fee and Modernization Act 2002. Required electronic medical device event reporting.MDR - Correct Answer System used for event Reporting for device manufacturers and importers Importer - Correct Answer Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations. Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 1 / 3
Relabeler - Correct Answer Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.Repackager - Correct Answer Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).Device User Facilities - Correct Answer A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See "Medical Device Reporting for User Facilities", a guidance document issued by FDA.Manufacturer and User Facility Device Experience (MAUDE) database - Correct Answer contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.pharmacokinetics - Correct Answer what the body does to the drug (how metabolized). is currently defined as the study of the time course of drug absorption, distribution, metabo-lism, and excretion.pharmacodynamics - Correct Answer what the drug does to the body (e.g. lowers blood pressure, etc. ).is the study of the biochemical and physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and effect.CFR - Correct Answer has 50 titles; official compilation of regulations; updated yearly 2 / 3
Federal Register - Correct Answer Daily supplement to CFR Food, Drug and Cosmetic (FD&C) Act - Correct Answer 1938 and subsequent Acts; basic Food & Drug Law. Came about after the sulfanilamide contamination that killed a bunch of kids. Strengthened safety and labeling. Still only focused on safety (not yet efficacy).NAI - Correct Answer No Action Indicated OAI - Correct Answer Official Action Indicated VAI - Correct Answer Voluntary Action indicated EIR - Correct Answer Establishment Inspection Report - FDA summarizes the inspection and classifies it as NAI, VAI, or OAI.482 Form - Correct Answer FDA gives for official inspection notice 483 Form - Correct Answer inspection findings; have 15 days to respond with correction plan RFD - Correct Answer Request for Designation - to request a center for a combo product; FDA responds within 60 days. If not response, then request is granted. Can dispute it within 1 days of receipt (Request for Reconsideration).Pediatric Research Equity Act (PREA) - Correct Answer Mandatory Pediatric studies
- Categories of Communication from FDA - Correct Answer 1. Administrative meetings or
- Product application meetings
- regulatory communications (e.g., guidance docs, citizen petitions, etc.)
- Public administrative proceedings.
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communications